Actively Recruiting
Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's Choice of Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL Cancer
Led by Genelux Corporation · Updated on 2025-09-26
142
Participants Needed
16
Research Sites
248 weeks
Total Duration
On this page
Sponsors
G
Genelux Corporation
Lead Sponsor
N
Newsoara Biopharma Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This Phase 2, open-label, randomized study in non-small-cell lung cancer (NSCLC) is designed to evaluate the efficacy and safety of an intravenously delivered oncolytic vaccinia virus, Olvi-Vec, followed by platinum-doublet chemotherapy + Physician's Choice of Immune Checkpoint Inhibitor (ICI) vs. docetaxel for patients with advanced or metastatic NSCLC who have shown first disease progression (i.e., progressive disease not yet confirmed by further scan after initial scan showing progression) while on front-line treatment or maintenance ICI therapy after front-line treatment with platinum-doublet chemotherapy + ICI as standard of care.
CONDITIONS
Official Title
Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's Choice of Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histologically or cytologically confirmed advanced or metastatic non-small-cell lung cancer.
- Stage III or IV squamous or nonsquamous disease per AJCC 8th edition.
- Received at least 2 and up to 6 cycles of front-line platinum-based chemotherapy with immune checkpoint inhibitor therapy.
- First disease progression by radiological assessment while on front-line or maintenance immune checkpoint inhibitor therapy.
- At least one measurable target tumor lesion outside the brain per RECIST 1.1 by CT or MRI.
- Adequate kidney, liver, bone marrow, coagulation, and immune function.
- Women of child-bearing potential must have a negative serum pregnancy test before starting treatment.
- Willing and able to follow scheduled visits, treatment plans, imaging, and lab tests.
You will not qualify if you...
- Active and untreated urinary tract infection, pneumonia, or other systemic infections.
- Current symptomatic central nervous system metastasis.
- Uncontrolled systemic disease or conditions interfering with treatment evaluation or safety.
- Persistent toxicities grade 3 or higher from previous anticancer therapy, excluding alopecia and vitiligo.
- Need for additional immunosuppression beyond corticosteroids or maintenance prednisone doses over 10 mg daily.
- Use of antiviral agents active against vaccinia virus.
- Major surgery within 4 weeks before planned first dose or incomplete recovery from surgery.
- Prior virus-based gene therapy or cytolytic virus therapy.
- Vaccination against smallpox or monkeypox within 1 year of study treatment.
- Recent non-oncology vaccines within 2 weeks before planned first dose.
- Significant skin diseases like severe eczema, psoriasis, or unresolved skin injury.
- Known allergies to study drugs or their components.
- Severe hypersensitivity to immune checkpoint inhibitors or their excipients.
- Dementia, altered mental status, or psychiatric/social conditions limiting study compliance.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Pioneer Research Center, LLC
Bullhead City, Arizona, United States, 86442
Actively Recruiting
2
Clermont Oncology Center
Clermont, Florida, United States, 34711
Actively Recruiting
3
Oncology & Hematology Associates of West Broward
Coral Springs, Florida, United States, 33065
Actively Recruiting
4
Helios Clinical Research
Fort Lauderdale, Florida, United States, 33316
Actively Recruiting
5
Bioresearch Partner
Hialeah, Florida, United States, 33013
Actively Recruiting
6
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
7
Bioresearch Partner
Miami, Florida, United States, 33155
Actively Recruiting
8
Mid Florida Hematology and Oncology Center
Orange City, Florida, United States, 32763
Actively Recruiting
9
BRCR Medical Center, Inc.
Plantation, Florida, United States, 33322
Actively Recruiting
10
University of Maryland Medical Center Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
11
Michigan Hematology and Oncology Consultants
Dearborn, Michigan, United States, 48126
Actively Recruiting
12
Oakland Medical Group
Farmington Hills, Michigan, United States, 48336
Actively Recruiting
13
Gabrail Cancer and Research Center
Canton, Ohio, United States, 44718
Actively Recruiting
14
Texas Oncology - Austin Central
Austin, Texas, United States, 78745
Actively Recruiting
15
World Research Link
Baytown, Texas, United States, 77521
Actively Recruiting
16
Sheboygan Cancer & Blood Center
Sheboygan, Wisconsin, United States, 53081
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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